Kornimate/medical-research-clean huggingface dataset:
photobiomodulation for management of temporomandibular disorder pain

Conditions: Pain Related to TMD

Summary: photobiomodulation (pbm), is fda-approved for temporary relief of muscle and joint pain, but there is no indication for tmd. our goal in this study is to conduct a clinical trial of multimodal pbm for tmd pain. this study will be a double-blind, sham-controlled, randomized trial testing the efficacy of pbm for pain related to tmd.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 years and older * meets the cati pre-screening criteria during pre-screening visit \[participant-reported facial pain for at least 3 months and an average pain intensity rating for the week preceding cati of ≥30 on a numerical rating scale (nrs, 0-100)\]. * willing to provide signed and dated informed consent * willing to to comply with all study procedures and to be available for the duration of the study * meets diagnostic criteria for tmd (masticatory muscle disorder, 1 a: myalgia) during visit 0 * completes a minimum of 4 of 7 daily symptom diary (dsd) entries prior to visit 1 (randomization visit), and the weekly average pain score on this dsd is ≥30 of 100 exclusion criteria: * active rheumatologic disease * has a medical condition, laboratory finding, or physical exam finding (e.g., renal failure or dialysis, uncontrolled diabetes mellitus, or uncontrolled seizures) that precludes participation as determined by the investigator * initiated occlusal appliance therapy within 30 days prior to cati * initiated non-pharmacologic therapy, such as acupuncture, biofeedback, and/or tens within 30 days prior to cati * is in active orthodontic treatment * received any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 14 days prior to the cati * has a history of facial trauma or orofacial surgery within 6 weeks prior to cati * has a history of psychiatric hospitalization within one year prior to cati * currently pregnant or lactating * has a known hypersensitivity to laser therapy * currently being treated with chemotherapy or radiation therapy * is undergoing treatment with another investigational drug or treatment initiated within 30 days prior to the screening and baseline visit * initiated a new daily prescribed or over-the counter medication for the management of pain within 30 days prior to screening and baseline visit. * anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study as determined by the investigator
levetiracetam versus topiramate as adjunctive therapy to evaluate efficacy and safety in subjects with refractory partial onset seizures

Conditions: Epilepsy

Summary: to assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.


Eligibility criteria:
inclusion criteria: * male or female subjects from 16 to 80 years, inclusive. subjects under 20 years may only be included where legally permitted and ethically accepted * subjects with refractory epilepsy with partial onset seizure classifiable according to the international league against epilepsy (ilae). * subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding v1 according to ilae classification * subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding v2 according to ilae classification * subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding v1 and 4 weeks preceding v2) * subjects being uncontrolled while treated by 1 to 3 permitted concomitant aeds. * permitted concomitant aeds having been stable and at optimal dosage for the subject from at least 4 week before v1 and during 4 weeks preceding v2 and expected to be kept stable during the treatment period. exclusion criteria: * subjects presenting any generalized epilepsies classified as type ii according to the ilae classification (ref to publication from 1981) * subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification iii according to the ilae classification) * subjects suffering from special syndromes (classification iv according to the ilae classification) * history or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before v2. * presence of exclusively type ia non-motor seizures. * history or presence of status epilepticus within last 3 months preceding v1 or during baseline * history or presence of known pseudo-seizures * subjects who are currently on vigabatrin. (subjects who received vigabatrin in the past and have a normal visual field test are allowed.) * subject taking 1 or more of the following medications on a regular basis within 28 days prior to visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)

Keywords: levetiracetam topiramate epilepsy partial seizures
registration and fusion of real-time ultrasound with ct for lesion localization and characterization

Conditions: Kidney or Liver Tumors

Summary: acquire ct data and us and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization.

acquire ct data and us and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization. optimize image fusion algorithms for use in goal. develop registration algorithms that result in maximal lesional overlap with a clinically relevant difference in an epicenter location of ≤ 2 cm for lesional identification and, ultimately ≤ 0.3 cm for interventional procedures.

Eligibility criteria:
inclusion criteria: * focal lesion involving the liver or kidney bases on ct or mri imaging * liver lesion size \>5 mm and \ 5 mm and \<4 cm in diameter * age \>18 years old * patient has provided written informed consent exclusion criteria: * patient with cardiac pacemaker or defibrillator * pregnant or lactating woman * patient with severe iv contrast allergy (previous reaction to iv contrast not mitigated by appropriate premedication) * patient unable to give informed consent

Keywords: fusion ultrasound computed tomography
safety and efficacy of exendin 9-39 in patients with postbariatric hypoglycemia

Conditions: Postbariatric Hypoglycemia

Summary: this clinical study will evaluate whether taking an investigational drug called exendin 9-39 is safe, well-tolerated, and helps to prevent low blood sugar in people who have had bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (pbh).

this is a phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study in patients with refractory pbh. participants will be randomized and assigned in a 1:1 ratio to one of two treatment arms. all participants will receive 2 dosing regimens of exendin 9-39 and matching placebo self-administered via subcutaneous (sc) injection. participants will undergo in-clinic mixed meal tolerance test (mmtt) provocation with concomitant blood draws and symptom assessments.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of up to 40 kg/m2 * roux-en-y gastric bypass (rygb) surgery performed ≥12 months prior * diagnosis of pbh * at least 2 episodes during screening 2-week run-in phase of severe hypoglycemia exclusion criteria: * other cause of endogenous hyperinsulinism other than pbh * metabolic or bariatric surgical procedure other than rygb * history of non-rygb upper gi surgery * use of agents that may interfere with glucose metabolism
end-1: first line chemotherapy for advanced or recurrent endometrial carcinoma with carboplatin and liposomal doxorubicin

Conditions: Endometrial Cancer

Summary: the purpose of this study is to evaluate activity and toxicity of the combination of carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or recurrent endometrial carcinoma.

treatment is planned with carboplatin auc 5 given iv on day 1 and liposomal doxorubicin 40 mg/m2 given iv on day 1, with treatment repeated every 28 days. delays in treatment administration and dose reductions have been planned according to toxicity.

Eligibility criteria:
inclusion criteria: * cytologic / histologic diagnosis of endometrial carcinoma * indication for chemotherapy * age 75 years or less * life expectancy of at least 3 months * measurable disease \> 1 cm exclusion criteria: * previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated) * performance status (ecog) \> 2 * previous chemotherapy treatment * heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia) * leukocytes \< 4000/mm3, platelets \< 100000/mm3 * impaired renal function (creatinine \> o = 1.25 times the upper normal limit) or liver function (sgot or sgpt \> o = 1.25 times the upper normal limit) * present or suspected hemorrhagic syndromes * uncooperative and/or unreliable patients * patient's inability to access the center * refusal of informed consent

Keywords: advanced recurrent chemotherapy first-line
optical coherence tomography guided laser treatment of basal cell carcinoma

Conditions: Basal Cell Carcinoma; Superficial Basal Cell Carcinoma; Nodular Basal Cell Carcinoma

Summary: optical coherence tomography guided laser treatment of basal cell carcinoma

the purpose of this pilot study is to examine the treatment basal cell carcinoma (bcc) with laser technology under the guidance of optical coherence tomography imaging (oct). the laser modality that we plan to use is the long-pulse nd:yag 1064nm laser, which is a non-ablative laser already shown to effectively treat bcc. laser treatment of bcc has limited precedent in the literature, but the addition of oct has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. we propose to use oct imaging to guide the laser treatment to achieve optimal efficacy with minimized side-effects.

Eligibility criteria:
inclusion criteria: * ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative * ages 18 and older * seeks and is scheduled for treatment of a bcc previously confirmed with biopsy exclusion criteria: any of the following will exclude participation in the study: * inability to understand and/or carry out instructions * patients with a bcc lesion that requires excision. this would include relatively large lesions (\>2.5 cm diameter), lesions that penetrate deep into the skin beyond the depth of the oct image capture, high risk lesions as defined by the american academy of dermatology as recurrent and sclerosing subtype bcc, or metastases. * patients with periocular bccs which might expose the patient to risk of damage to eyes from the laser. * bccs on legs due to their tendency towards poor wound healing. * pregnancy * patients unable to follow-up for the full 12 months.

Keywords: basal cell carcinoma superficial basal cell carcinoma nodular basal cell carcinoma optical coherence tomography oct laser
sciatic perineural versus stump catheter for below knee amputation

Conditions: Ischemia; Phantom Limb Pain; Vascular Disease; Chronic Pain

Summary: the goal of this study is to determine if pre-operative placement of the continuous peripheral nerve block by an anesthesiologist using ultrasound technology is more effective than a continuous peripheral nerve block placed during the surgery by a surgeon for patients undergoing a limb amputation

we wish to determine the most effective site for the continuous infusion of local anesthetic for patients undergoing amputation of a limb. the information we obtain from this study will help to decide the most effective manner to provide pain relief for patients in the future. the primary outcome of interest is post-operative pain relief as measured by the amount of pain-relieving medications (opioids) required by patients prior to discharge home. the secondary outcomes of interest will be pain-relieving medications (opioid) requirements during the operation, length of stay in the hospital, time required for mobility, and patient satisfaction- measured by a survey given while in hospital and 3 months later.

Eligibility criteria:
inclusion criteria: * undergoing a below knee amputation * 16 years of age or older * regional anesthetic will be used as part of the surgery exclusion criteria: * pregnant * allergic to local anesthetic or ultrasound jelly * a contraindication to having a peripheral nerve block catheter

Keywords: sciatic catheter stump catheter below knee amputation
safety study of s-caine peel (skin numbing cream) before a painful dermatologic procedure in adults

Conditions: Pain

Summary: the purpose of this study is to evaluate the safety of one treatment of s-caine™ peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. this study will also evaluate how well the s-caine™ peel eases the pain of the procedure.

the practice of dermatology is seeing a rise in the number of surgical and laser procedures as technological advances have expanded the number of conditions amenable to these evolving therapies. skin biopsies, shave excisions, deep excisions, electro-surgical procedures, intralesional injections, and laser surgery are frequently performed by dermatologists on a daily basis. some pain accompanies almost all of these procedures, and a local anesthetic is commonly used. traditionally, intracutaneous injection of lidocaine (with or without epinephrine) has been the anesthetic of choice. however, patients undergoing these procedures are often afraid of needles and syringes and the pain associated with injections. as a result, topical anesthetic agents have been explored and developed as painless alternatives to injected anesthesia. s-caine™ peel (lidocaine 7% and tetracaine 7% cream) consists of a new eutectic formulation of lidocaine and tetracaine. s-caine peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. s-caine peel is not occluded during application. the purpose of this study is to gain additional safety information for s-caine peel when used in minor and major dermal procedures in adults.

Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older. * patient elects to undergo a minor or major dermal procedure. * patient is able to read and understand a written informed consent and has signed and dated a written informed consent. exclusion criteria: * patient has known allergies, contraindications or sensitivities to lidocaine, tetracaine, or other local anesthetics of the amide or ester type or to any components of the test materials. * patient has known active atopic dermatitis at the designated treatment site. * patient has damaged, denuded or broken skin at the designated treatment site. * patient is pregnant or breastfeeding. * patient has participated in an investigational study or clinical trial of an unapproved drug within the previous 30 days. * patient has enrolled in any previous study involving s-caine peel.

Keywords: pain
satisfaction assessment of patients with local breast cancer when using cosmetics during chemotherapy and post-treatment thermal cure

Conditions: Local Breast Cancer Patients

Summary: the purpose of this study is to assess the satisfaction, the observance, the intolerance, the qualitative appreciation and the expectations of the patients related to the use of the cosmetic products ("tendre caresse au cold cream" body cream and "crème de douche" face and body cleanser from cosmétosource) during chemotherapy and post-treatment thermal cure


Eligibility criteria:
inclusion criteria: * woman, * age \> or = 18 years, * performance status \> or = 1 (according to who criteria), * patient with histologically proven breast cancer, not metastasized, * patient treated with neoadjuvant or adjuvant chemotherapy, * absence of cutaneous lesions related to the pathology, * patient fluent in the french language, * patient affiliated to a social security scheme, * obtaining written, signed and dated informed consent. exclusion criteria: * metastatic breast cancer, * local relapse of breast cancer * history of cancer in the 5 years preceding the entry into the trial, * patient already treated with chemotherapy, * medical contraindications to the use of cosmetic products and the prescription of a spa treatment, * patient deprived of liberty or under guardianship.

Keywords: breast cancer cosmetics satisfaction chemotherapy thermal cure
evaluation of changes in pancreatic fat content using advanced mr sequences in diabetics on dapagliflozin therapy

Conditions: Pancreatic Lipomatosis

Summary: the study aimed to assess changes in pancreatic fat content in people with diabetes on dapagliflozin (sglt2 inhibitor) and beta cell function.

the study assessed and estimated the difference in pancreatic fat content in the patients of type 2 diabetes mellitus at baseline and after taking dapagliflozin for 24 weeks. the investigators even estimated the correlation between two advanced mr techniques commonly used for quantification of pancreatic fat (pdff and mr spectroscopy)

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, 2. hba1c 7-11%, 3. renal function (mdrd) \> 30 ml/min, on glucose-lowering therapy {metformin, sulfonylureas, glinides, dipeptidyl peptidase-4 (dpp-4) inhibitors, or basal insulin} at a stable dose for at least 3 months. exclusion criteria: 1. uncontrolled hyperglycemia at screening (fasting blood glucose fbg ≥ 240 mg/dl). 2. diabetes other than type 2 diabetes 3. age younger than 18 years. 4. pregnant patients or lactating. 5. patients who refuse to give consent to be enrolled in the study. 6. any contraindication to magnetic resonance imaging. 7. more than 5% total body weight loss within the last month. 8. patients with moderate or severe renal impairment 9. any contraindication to sglt2i 10. prior sglt2i within the past 3 months

Keywords: dapagliflozin pancreatic fat mri diabetes mrs
first in-human use of setalum™ sealant: the blueseal clinical study

Conditions: Vascular Diseases

Summary: this is a prospective, multicenter, single-arm trial to evaluate the safety and performance of setalum™ sealant in sealing suture lines at the anastomosis between native vessels and synthetic eptfe vascular patch used during open vascular surgery.


Eligibility criteria:
inclusion criteria: * ≥18 years old; * surgical placement of an eptfe patch for large carotid repair; * written informed consent given by the patient. exclusion criteria: * known or suspected allergy or sensitivity to any test materials or reagents; * concomitant intake of immunosuppressive medications; * prior radiation therapy to the operating field; * previous surgical procedure performed on the same operating field; * current or recent (\<3months) participation in another investigational study; * refusal to receive blood products; * pregnant or breast-feeding women
urea and creatinine level in vaginal fluid as a predicator for length of latency period in prelabour membranes rupture

Conditions: Rupture of Membranes; Premature

Summary: this study aims to investigate the relation between the concentration of urea and creatinine in vaginal fluid and length of latency period in women with prom between 32 and 35 weeks gestation.

60 pregnant women with prom with singleton pregnancies with a gestational age between 32- 35 gestational weeks history taking followed by examination all women will be put in dorsal lithotomy position, using a proper light source and sterile gloves; sterile speculum free of gel will be placed into vagina. for every woman a specimen of vaginal fluid will be taken as follows: 5 ml of sterile saline solution will be injected into the posterior vaginal fornix taken after aspiration of 3ml with the same syringe. all samples will be obtained within 6 hours after membranes rupture before vaginal examination and the administration of any drugs. upon collection, samples were centrifuged at 3000 rpm for 10 minutes and supernatant fluid was separated. exact concentrations of urea and creatinine will be measured all women will be put under observation for 48 hours and time of onset of delivery will be documented, the onset of labor will be diagnosed by either: 1. frequent uterine contractions more than 2 contractions in 10 minutes. 2. ctg showing frequent contractions.

Eligibility criteria:
inclusion criteria: 1. maternal age between 20-35 years. 2. 32-35 weeks gestational age. 3. viable fetus. exclusion criteria: 1. vaginal bleeding either spontaneous or traumatic e.g. placenta previa. 2. chorioamnionitis. 3. multiple pregnancy. 4. presence of uterine contractions. 5. amniotic fluid disorders e.g. polyhydramnios 6. meconium stained amniotic fluid prior to active phase of labor. 7. maternal disease necessitating termination of pregnancy e.g. severe preeclampsia

Keywords: prom
a prospective trial of an endoscopic quality improvement project

Conditions: Colon Polyps

Summary: randomized prospective multi-site validation study.

gi practice sites that have recently agreed to participate in the giquic program will be randomized on a site-basis, to the equip intervention or control. baseline adr and polyp/surveillance predication accuracy will be collected for approximately 3 months. sites randomized to the equip intervention will undergo face-to-face training by a study investigator, followed by active monitoring and feedback. control sites will not receive supplemental training and will be monitored by with no feedback. after completion of the study all sites will be offered the intervention (as is standard feedback in giquic ).

Eligibility criteria:
inclusion criteria: * endoscopy centers that are new to giquic and have not yet received training * all endoscopists performing screening and surveillance colonoscopy at the participating center will be invited to participate exclusion criteria: * cases that involve acute indications such as bleeding and active colitis will not be included in data pool * patients with a family or personal history of a polyposis syndrome or with a personal history of inflammatory bowel disease will also be excluded * procedures that are deemed incomplete will be excluded * patients with surgically altered anatomy (i.e. prior colectomy) and with poor bowel preparation (boston bowel preparation score \ 5mm) will be excluded

Keywords: adenoma detection adenoma prediction